DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The Amendment filed 05/11/2026 has been entered. Applicant’s amendments are in response to in the Non-Final Office Action mailed 11/13/2025. Applicant’s claims have been amended in the following manner: independent claim 1 has been modified by the list of formulation types. Furthermore, new claims 23-27 (inclusive of plant extract species and “user in need of stimulation of the lymphatic system” by application of a cosmetic preparation) have been entered to draw a new ground of rejection to address the user population (i.e., Yimam), and there is also further clarification of obviousness vs. unexpected results. Also, the Examiner wants to note a discrepancy in the extract biological activity of the library screening data (i.e., evidentiary reference Zhang discusses HTS reliability and confirmatory testing) of the Affidavit (Table 1, pg 3-11) (filed 05/11/2026), as compared to the data for Examples 1-3 of the Specification (and Figures 1-6), whereby resolution/explanation of the different sets of Applicant’s data could help move the case forward (see discussion below in response to the remarks/Affidavit for further details).
The following objections/rejections are withdrawn: 101 rejection (based on amendment of dosage forms), and claim objections (based on Applicant argument).
The Examiner further acknowledges the following:
Claims 1-2, 4, 8, 10-13, 15-18, and 21-27 are pending.
Claims 1-2, 4, 8, 10-13, 15-18, and 21-27 are presented for examination and rejected as set forth below.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2, 4, 8, 10-13, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Ragot (US 2015/0056255A1), in further view of Faller (US2008/0260869A1) and Behr (US20070122492 A1).
Applicants claims are directed to a cosmetic preparation (i.e., a composition) that “comprises” various plant extracts at specified amounts and a method of use. It is noted that claims 15-18 name plant extracts of specific species of the instant genera. For claim 22, note that a recitation of an intended use will not limit the scope of the claim because it merely defines a context in which the invention may operate. Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003). Thus, “suitable to stimulate the lymphatic system” describes an intended use of the composition, and is not given weight.
Furthermore, direction for “stimulate the lymphatic system” is found in the Specification on pg 7: “stimulation of the lymphatic system: lymph vessels fulfill an important role in order to maintain the microenvironment surrounding tissue in a constant state by removing unwanted substances present in skin as well as water and protein constantly escaping from blood vessels. It was found that plant extracts as described herein activate the lymphatic system, particularly the lymphatic vasculature” where activation is demonstrated by sprouting and migration of cultured human lymphatic endothelial cells (pg 7, Specification). Applicant demonstrates sprouting at 0.05% and 1% for example (pg 13, Specification).
For the method claims (instant claims 8, 10-13, and 15-16), the phrase “skin in need thereof a cosmetic preparation” is interpreted broadly to mean any skin in need of any cosmetic preparation and does not specify a particular subject population or skin condition for treatment. The skin benefiting method outcomes of instant claim 8 and 10-13 (i.e., to stimulate the lymphatic system, but also rejuvenation of the skin, anti-aging of the skin, etc.) are not given weight, in an obviousness rejection. It must be remembered that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005) (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). Thus, a method of treatment is generally defined by active steps, composition structure, and patient population. Weight can be provided to a method outcome, if the instant claims are able to argue a new and non-obvious result (the Examiner discusses the method outcome, regarding the lymphatic stimulation, which appears to be the focus of Applicant’s arguments, in the arguments section below).
Furthermore, in the method claims, there is a mix of skin conditions (i.e., puffy eye, swollen skin) which are given weight by specifying user location (e.g., the eye) and/or skin condition (e.g., puffy/swollen skin), and other method outcomes (which are addressed in the paragraph above; i.e., rejuvenation of the skin, anti-aging of the skin, etc.), which are addressed in the rejection below. Note that patentable weight for a method of treatment is afforded to defining patient populations to be treated, as defined by a disease or skin condition (e.g., puffy eye; however, as shown below, the method of treating puffy using these kinds plant extracts is obvious from the literature).
Ragot discloses a product for medicinal, cosmetic, coloring, or dermatologic use, that comprises one or more plant extracts that can be applied on the skin (Ragot – claims 1-4, [0014]).
Regarding claims 1-2: Ragot teaches a product for dermatologic use (Ragot – claim 1) comprising plant extracts from Artemisia spp., Echinacea angustifolia, Equisetum arvense, and Salvia spp. (which reads on the instant geniuses of instant claims 1-2) (Ragot – claims 5 and 6). Ragot teaches the plant extract to be at least 30% by weight in the composition (Ragot – claim 16), which is near the upper limit of 20 wt% of the instant claims. Furthermore, Ragot teaches that the extract can be concentrated (which could be read as “enrichment”) or purified (Ragot – claim 41, step (e)). Ragot teaches the product to be a cream, a foam, a liquid, or a powder (Ragot – claim 18). Ragot teaches hyaluronic acid [0066] and collagen [0067].
Furthermore, with respect to the number of plant genera and species used in topical cosmetic application, named by Ragot: it is well settled that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands. Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985).
Regarding claim 4: Ragot teaches incorporation of additional substances, including emulsifiers, scents, preserving agents, vitamins, essential oils, coloring agents, etc. [0088, 0091].
Regarding claims 21: Ragot teaches that the plant extract can come from certain parts of the plant such as the root, bark, leaf, fruit, or flower [0007]. Ragot teaches a method to obtain plant extract, using polar or apolar solvents [0020-0030].
Regarding claim 22: Stimulation of the lymphatic system is an intended use of the composition, and a recitation of an intended use will not limit the scope of the claim because it merely defines a context in which the invention may operate. Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003).
In summary, Ragot teaches a composition comprising elements (including plant extracts) of the instant composition for cosmetic use except for the amounts of claim 1. However, Ragot does not teach the specific amounts (instant claim 1) and the “the method of applying to skin in need thereof a cosmetic preparation” (instant claims 8, 10-13).
Faller teaches topical compositions comprising plant extracts (including artemisia abrotanum) (abstract), where artemisia abrotanum is used in 4 wt% (Table 1) (within the instant amounts of claim 1) but also teaches a very wide range 0-99 wt% of ingredients [0020, 0092] in determining the effective amount of active such that a person would optimize the amount of active [0023, 0028], and this plant extract is known for treatment of puffy eye (reads on puffy eye/swelling of instant claims 8, 10, 11, and 13) [0012-0013, 0054]. Faller teaches a method of applying the composition for skin conditions such as puffy eyes and wrinkles (Faller – claims 33-37 and 44-48).
Behr further teaches cosmetic compositions for skin sagging (abstract) or swelling [0166] that incorporate plant extracts of Echinacea [0197], Artemisia [0197], Salvia [0197], and Equisetum [0197] to treat skin ageing, where the final effective amount of extract used in a composition would be tied to the desired beneficial effect of skin improvement ([0014], [0186], abstract). See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the amount of extract in Ragot’s composition to the amount range taught by Faller because the amount of extract used is typical in the arts for skin improving effects, as in Faller’s teaching. Furthermore, Behr and Faller discuss optimizing amount of plant extract based on desired activity to provide effective skin treatment. It is noted that Ragot desires to achieve a medicinal, cosmetic, or dermatological effect (abstract). Furthermore, the amount of active ingredients within a plant extract is not well defined (as plant extracts can be dilute or concentrated), and thus, a PHOSITA would be expected to optimize the amount of total extract applied in the composition.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to apply Faller’s method of applying a composition to skin in need thereof a preparation for treatment of puffy eye or loss of firmness to Ragot’s teaching because Ragot, Fallers, and Behr both teach compositions comprising plant extracts (including the instant plant genera) intended to treat puffy eye and swelling. Ragot also targets the eyes [0078] and has interest in plants with anti-inflammation, anti-aging, and anti-wrinkle effects [0088, 0106].
With respect to the obviousness of the composition and method, remember that “to stimulate the lymphatic system” is not currently given weight because this is a method outcome and does not represent a limitation that affects the active steps of the method (see claim interpretation above). The discussion regarding the unexpectedness of results will be addressed below in the ‘response to arguments’ section.
Claims 1-2, 4, 8, 10-13, 15-18, and 21-27 are rejected under 35 U.S.C. 103 as being unpatentable over Ragot (US 2015/0056255A1), Faller (US20080260869A1), and Behr (US20070122492 A1), as applied to claims 1-2, 4, 8, 10-13, and 21-22, in further view of Makerri (US20190336884A1) and Yimam (Pharmacogn. Res., 2017).
As discussed above, Ragot, Faller, and Behr teach a cosmetic preparation comprising various species and genus of plant extracts at specified amounts, and a method of applying topically for treatment of skin conditions such as puffy eye or loss of firmness. However, they do not teach all of the specific species (including Salvia hispanica and Artemisia vulgaris) of the preparation or the method (instant claims 15-18, 23-24, and 26-27) or the “skin of the user in need of stimulation of the lymphatic system” (instant claim 25).
Makerri teaches plant extracts of Salvia hispanica, Artemisia abrotanum, and Artemisia vulgaris [0075] (where Ragot teaches Artemisia spp., Echinacea angustifolia, Equisetum arvense, and Salvia spp. (Ragot – claims 5 and 6) for cosmetic use) for use in topical dermatological or cosmetic compositions [0028, 0086] where the extract is used in 1x10-4 to 10 wt% in the composition [0087] (also overlapping the instant amounts of claim 1) to improve the health or physical appearance of facial and body skin [0090, 0093].
Yimam identifies patient group (e.g., in need of cellulite treatment) in need of cosmetic treatment (abstract), including use of topical plant extracts (e.g., R. aculeatus and Hedera helix) that improve lymphatic drainage (thus, reads on “user in need of stimulation of the lymphatic system” by topical application of a plant extract preparation that improves lymphatic drainage) (pg 323, left column). Yimam teaches cellulite represents one of the main esthetic concerns of women with a likely cause of psychological insecurities that may lead to a desperate need for cosmetic or treatment interventions with dimpled or puckered skin appearance (pg 319, paragraph 1, abstract) that can be related to abnormal fat deposition, lymphatic drainage, etc. (pg 320, paragraph 1).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined Prior Art composition with the plant extract species taught by Makerri because they are specific species of plant genera taught generally by Ragot for the same outcome of skin improvement. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined Prior Art method to be directed to users in need of lymphatic activation (e.g., individuals with cellulite), as taught by Yimam, because Yimam teaches cellulite represents one of the main esthetic concerns of women with a likely cause of psychological insecurities that may lead to a desperate need for cosmetic or treatment interventions with dimpled or puckered skin appearance (pg 319, paragraph 1, abstract) that can be related to abnormal fat deposition, lymphatic drainage, etc. (pg 320, paragraph 1), and the combined Prior Art generally teaches application of plant extracts toward the improvement of the appearance of skin (e.g., see Faller at [0023] for fat production of skin, firmness, etc. as related to having cellulite).
Response to Arguments
Applicants arguments, see pg 8-15, filed 05/11/2026, with respect to the 103 rejection of claims 1-2, 4, 6, 8, 10-13, 15-19, and 21-22 under rejection have been fully considered but they are not persuasive (as discussed below). The 103 rejection has been modified with respect to amendments made to the claim set and new added claims. Notably Yimam is added to address the new “user in need of stimulation of the lymphatic system” population of instant claim 25.
On page 8, Applicant addresses the 101 rejection and claim objections which are both resolved. The Examiner agrees with Applicant’s approach.
On page 9, Applicant argues that the combined Prior Art does not guarantee Applicant’s specific benefit of activation of the lymphatic system. in terms of obviousness, note that intended uses do not have patentable weight in the obviousness analysis of a composition. Thus, compositions that comprise the instant compounds in the instant amounts that are known to the Art, whether or not they consistently active the lymphatic system or not (in terms of an obviousness analysis).
Furthermore, in regard to the assertion that Applicants haven’t been provided a rationale for selecting these components from among the list, the Examiner directs Applicant to the rationale of the 103 rejection. In terms of obviousness, it is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Lintner, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972) (discussed below); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991), In this case, each of the components are described by the art as conveying to a topical composition continuing them certain beneficial effects for skin, whereby the combination of the ingredients would lead to an effective topical composition. Thus, selection does not need to occur on the basis of Applicant’s motivation, regarding lymphatic activation.
Furthermore, with regard to the list of species disclosed by the Prior Art: It is well settled that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands. Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985). Thus, in an obviousness rejection, the number of species to select from within a primary reference in order to provide a skin benefit is not relevant. Thus, the combined Prior Art teaches plant extracts to treat various skin conditions (i.e., cosmetically or therapeutically), including skin conditions such as puffy eyes, wrinkles, swelling, inflammation, cellulite, etc.
Finally, in an obviousness analysis, it is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Lintner, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972) (discussed below); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991). The rationale to combine the Art is specifically provided in the 103 rejection above, where benefit of skin is the general purpose. In consideration of specific ingredients of the Prior Art: Makerri teaches plant extracts of Salvia hispanica, Artemisia abrotanum, and Artemisia vulgaris [0075] (where Ragot teaches Artemisia spp., Echinacea angustifolia, Equisetum arvense, and Salvia spp. (Ragot – claims 5 and 6) for cosmetic use) for use in topical dermatological or cosmetic compositions [0028, 0086] where the extract is used in 1x10-4 to 10 wt% in the composition [0087] (also overlapping the instant amounts of claim 1) to improve the health or physical appearance of facial and body skin [0090, 0093].
On page 9-11, in response to the will result in the disclosed effect of stimulation of the lymphatic system (i.e., a proposed unexpected result), and Applicants further claims of an unexpected result, the Examiner directs the reader to the discussion apparent discrepancies in the data of the Affidavit below in the ‘Response to Amendment’ section (i.e., inclusive of a discussion regarding the Table 1 of the Affidavit (pg 3-11), compared to Examples 1-3 of the Specification with reference to Figures 1-6). Refer to the ‘Response to amendment’ section below, for a summary of the inconsistent nature of the data (i.e., data of the Affidavit and Specification), and therefore the inconclusive result associated with the filed data.
Applicant is reminded, to counteract an obviousness rejection: “[A]ppellants have the burden of explaining the data…they proffer as evidence of non-obviousness.” Ex parte Ishizaka, 24 USPQ2d 1621, 1624 (Bd. Pat. App. & Inter. 1992). The evidence relied upon should establish “that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance.” Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). Thus, the discrepancy of data discussed in the Affidavit section below requires suitable resolution in order to proceed with this line of argument.
On page 11-12, Applicant argues against the inherency argument of the Office (i.e., as related to “stimulation of the lymphatic system.” Whether or not lymphatic stimulation is an inherent property of plant extracts generally or of species in particular, is a position the examiner does not concede. Note that Makerri teaches plant extracts of Salvia hispanica, Artemisia abrotanum, and Artemisia vulgaris [0075] (where Ragot teaches Artemisia spp., Echinacea angustifolia, Equisetum arvense, and Salvia spp. (Ragot – claims 5 and 6) for cosmetic use) for use in topical dermatological or cosmetic compositions [0028, 0086] where the extract is used in 1x10-4 to 10 wt% in the composition [0087] (also overlapping the instant amounts of claim 1) to improve the health or physical appearance of facial and body skin [0090, 0093]. Thus, the Art teaches as obvious, a method of applying compositions containing the instant extracts (which are demonstrated as obvious in the appropriate amounts) because the Art teaches the same ingredients and amounts as obvious (thus, any additional advantages or latent properties would necessarily flow from a method of topically applying the instant ingredients taught by the Prior Art onto skin).
However, if Applicant choses to rely on an unexpected results argument (i.e., by restricting composition 1 to the specific instant ingredients and amounts, the unexpected result of lymphatic activation is consistently produced) in order to afford weight to the method outcome (consistent with the case law provided by Applicant on pg 11-12), then this argument must be supported by objective data, and furthermore, the claims must be commensurate in scope with the objective data representing the unexpected result.
Further clarification of this discrepancy is required in order to demonstrate non-obviousness based on an unexpected result argument.
On page 12-13, Applicant argues against each reference individually which is per se unpersuasive. Furthermore, each reference is reasonably analogous to the instant invention. Finally, each individual reference need not teach all elements, because it is the combined teachings that represent the Art in an obviousness analysis.
On page 13-14, Applicant refers to Ragot’s teaching as leading away from lymphatic stimulation. Note that in an obviousness analysis, the rationale to combine need not be the same as Applicant (i.e., lymphatic stimulation): In an obviousness analysis, it is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Lintner, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972) (discussed below); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991). The rationale is supplied in the 103 above, and generally centers around benefit of the skin by topical application of a composition. Specifically, the combined Prior Art teaches the obviousness of combining plant extracts in order to afford skin benefitting compositions for topical application, including skin conditions such as puffy eyes, wrinkles, swelling, inflammation, cellulite, etc.
Further note, that Ragot does not explicitly teach away from a composition of plant extracts . In order to teach away from a proposed modification, the art must “criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). The art does not criticize, discredit, or otherwise discourage the modification proposed by the Examiner.
On page 13-14, Applicant argues in favor of providing weight for lymphatic stimulation as a method outcome (i.e., “to stimulate the lymphatic system” of method claim 8) for the method claims. The Examiner reiterates the interpretation provided in the 103 rejection (for an obviousness analysis): With respect to the obviousness of the composition and method, remember that “to stimulate the lymphatic system” is not currently given weight because this is a method outcome and does not represent a limitation that affects the active steps of the method (see claim interpretation above). Moreover, the data of the Affidavit and Specification are in conflict, and do not support the proposed method outcome (see ‘response to amendment’ section below for a discussion of the Affidavit in relation to the Specification).
Furthermore, rationale has been provided whereby the stimulation of the lymphatic system would necessarily flow from the obviousness of applying the plant extracts taught by the Art. When the Art teaches the obviousness of the instant ingredients and amounts for topical cosmetic products, then a method of applying those ingredients and amounts, then the stimulation of the lymphatic system, as an additional advantage or latent property, would necessarily flow from the active method steps that are taught as obvious of the Art.
However, if Applicant choses to rely on an unexpected results argument (i.e., by restricting composition 1 to the specific instant ingredients and amounts, the unexpected result of lymphatic activation is consistently produced) in order to afford weight to the method outcome (consistent with the case law provided by Applicant on pg 13-14), then this argument must be supported by objective data, and furthermore, the claims must be commensurate in scope with the objective data representing the unexpected result.
On page 14, Applicant argues impermissible hindsight reconstruction. As for the assertion that the rejection is based on hindsight, as noted in MPEP 2145, “[a]ny judgment on obviousness is in a sense necessarily a reconstruction based on hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill in the art at the time the claimed invention was made and does not include knowledge gleaned only from applicant’s disclosure, such a reconstruction is proper.” In re McLaughlin, 443 F.2d 1392, 1395, 170 USPQ 209, 212 (CCPA 1971). The Examiner has pointed to nothing other than what the art available at the time the instant application was filed to teach or suggest each and every limitation of the invention claimed, and relied on nothing other than the art to rationalize their combination in the manner you put forth. In the case of obviousness, appropriate rationale is provided from combination. Therefore, this argument is not persuasive.
On page 15, Applicant argues based on new claims 23-27. Note that the Art teaches all of the species as obvious for a skin-benefiting topical cosmetic. See discussion of Affidavit and Specification data below, with respect to a proposed unexpected result that is argued on pg 10-11.
Response to Amendment
The affidavit under 37 CFR 1.132 filed 05/11/2026 is insufficient to overcome the rejection of claims 1-2, 4, 6, 8, 10-13, 15-19, and 21-22 based upon the 103 rejection as set forth in the last Office action because:
On pg 3-11, Applicant discloses a table with extract activity in the Affidavit. With respect to the table of the Affidavit library screen (Table 1, pg 3-11), there are several species (i.e., represented by the instant claim scope) that have inconsistent results (e.g., including Equisetum arvense of instant claim 27, as shown below, from page 7 of the Affidavit).
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Furthermore, the Examiner notes that the species of the genus Salvia, Artemisia, Echinacea, Equisetum, and Artemisia (i.e., per instant claims 1-2) have both positive and negative results. With regard to unexpected results (see pg 10 or the remarks, where Applicant claims evidence of unexpected results), the results from the Affidavit library screen (Table 1, pg 3-11), are as follows: Salvia hispanica (n/a), Artemisia vulgaris (positive, neutral, negative), Echinacea angustifolia (neutral, negative, negative), Equisetum arvense (positive, neutral), Artemisia abrotanum (n/a).
Finally, Applicant explains that many extracts showed a neutral effect (no significant change from control), and a substantial number showed an inhibitory effect (reduction in sprouts/bead relative to control, where the control is noted as “Glycerol” which is not expected to have a lymphatic stimulatory activity, based on Applicant’s Specification on pg 3, paragraph 3). In the below graph, where 1 sprout/bead compared to control is interpreted to mean a “neutral effect”, the Examiner questions the reliability of the library screen data, when the replicate data can result in such different results.
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However, this data appears to be in conflict with the data of Example 1-3 of the Specification (see below for pg 12 Specification data, regarding Figure 2 that appear to relate to library screening data). In the below case, Equisetum arvense have a 1 and 0.9 value, which the Examiner would interpret as a neutral effect in both data points, based on the discussion of the meaning of the data in the Affidavit. Thus, the objective data supporting an unexpected result are not convincing and require further explanation and/or resolution.
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Furthermore, Example #5 (i.e., Artemisia abrotanum) is buried amongst all other data points in terms of magnitude (Figure 2, screening data). It is unclear with respect to what data point this Figure is normalized to (i.e., how does 0.57 sprouts/bead better than the control composition, or is there even a control composition). Based on the position of #5 in Figure 2, there is an appearance of every data point having (or maybe not having) LEC activity.
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The Examiner notes Figures 3-6 appear to be confirmatory-type studies that are limited to specific species. Further explanation could be provided that differentiates the data in Figures 3-6 from the library screening results. In fact, Zhang (J. Comb. Chem. 2000) teaches that high throughput screening has reliability issues and often relies on confirmatory testing to determine if a “hit” is truly active. (abstract).
Thus, due to the conflicting data supporting the unexpected result argument, the composition and method claims remain under rejection, in terms of obviousness. The claims will remain under rejection until the discrepancy between the Affidavit Table (pg 3-11) and Examples 1-3 (Fig 1-6) are suitably clarified, and a persuasive argument of unexpected results is presented. To counteract an obviousness rejection: “[A]ppellants have the burden of explaining the data…they proffer as evidence of non-obviousness.” Ex parte Ishizaka, 24 USPQ2d 1621, 1624 (Bd. Pat. App. & Inter. 1992). The evidence relied upon should establish “that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance.” Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992).
Additionally, something noticeable about the data on pg 3-10 is that almost every data point has a positive or negative effect, that does not appear consistent across genera or even species. Therefore, there is an expectation that an extract from any species will have some effect on lymphatic stimulation (i.e., it is an additional advantage or latent property” of the plant extracts). It is somewhat unclear if the lymphatic drainage has a primary benefit in topical compositions of the Art, or if the skin benefitting results are due to the specific compounds that make up each individual plant extract (whereby the amount and type of compounds may vary by individual plant and/or extraction method). Applicant bears the burden of establishing the significance of lymphatic stimulation in topical application of the instant plant extracts, if Applicant decides to argue on the basis of unexpected results.
Furthermore, the irregular results of the Affidavit library screen (Table 1, pg 3-11), compared to the data of the very specific species of Figures 3-6 must be weighed in terms of extrapolating any proposed validated unexpected result, such that the confirmed unexpected results are commensurate with the claim scope (i.e., what objective data represents reliable information upon which to make a decision the breadth of genera and species covered by the claim scope). Note: whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980).
Correspondence
Applicant's amendment necessitated the new ground of rejection presented in this Office action. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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/R.P./Examiner, Art Unit 1614 6/11/2026
/SEAN M BASQUILL/Primary Examiner, Art Unit 1614
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